IRB Reliance Exchange Terms of Use

The IRB Reliance Exchange portal (“IREx”) is an online portal that facilitates the Single Institutional Review Board (“sIRB”) review process of multi-site human subject research studies (each, a “Study”). IREx is used to track sIRB-related processes and exchange Study-related administrative documents and other communications among institutions participating in the Study (each, a “Participating Sites”). IREx is operated and provided at no charge by Vanderbilt University Medical Center (“We” or “Us” or “Our”) for use by Participating Sites solely for purposes of the applicable Study, and solely in accordance with these terms of use (“Terms”). By registering to use IREx, clicking “I agree”, or otherwise accessing or using IREx, you represent that you are acting as an authorized representative of your institution, and that you and your institution (collectively, “You”) agree to be bound by these Terms.

Scope of Use. IREx is available to researchers, staff, institutional representatives, and IRBs performing sIRB review of multisite studies, as well as authorized third parties and IREx staff. Information uploaded and shared through IREx is solely for purposes of facilitating the sIRB review process, including IRB reliance decisions, submission of local considerations, and documentation of IRB approval. Any use of IREx not reasonably related to these functions is prohibited. You may only submit data and information to IREx for which You have obtained all necessary and required consents, permission, and authorizations, and You must make every effort to ensure data and information provided to IREx is accurate.

Access to IREx. Only authorized personnel of a Participating Site in a Study or an applicable IRB and IREx staff may access IREx, and all access is subject to these Terms. You are responsible for administering IREx access permissions and credentials for users at Your institution, and for designating which Participating Sites may access Your Studies. You may not provide access to IREx for any person outside of your institution. You may terminate Your access to IREx and these Terms as they pertain to You (except Sections 5-8 and 11) at any time.

IREx Operations.

Generally. Subject to these Terms, We will use commercially reasonable efforts to host and make IREx available to You on a continuous basis (except during maintenance and unforeseeable events). We have no obligation to verify the identity of any person who gains access to IREx through credentials issued to, or by, You. As between You and Us, You are solely responsible for any access to, or use of, IREx through credentials or permissions issued to, or by, You, and for any noncompliance with these Terms by Your personnel or anyone using such credentials or permissions. You must terminate IREx access credentials and permissions for any of Your personnel who no longer require IREx access (whether due to termination of employment, cessation of current job position, or otherwise). We reserve complete and sole discretion with respect to the operation of IREx. We shall have the right to conduct audits of Your compliance with these Terms. We may, among other things, suspend, withdraw or discontinue Your access to IREx as we deem appropriate. Subject to the foregoing, We will maintain commercially reasonable security procedures intended to protect IREx and related data from unauthorized access. However, You must notify Us promptly of any suspected security incident regarding IREx or the transmission of data to or from IREx of which You become aware, including any compromise of access credentials. We may suspend or terminate Your access to IREx in the event that We determine that there is a security risk related to the proper and continued operation of IREx.

Restrictions. You may not, and You may not allow any person to: (a) use, copy, or modify any portion of IREx or any data stored in, or available through, IREx, except as expressly permitted by these Terms and in compliance with the applicable Reliance Agreement; (b) reverse engineer, disassemble, decompile, rent, lease, or transfer IREx or access to IREx; (c) use of IREx for any unlawful purpose or in furtherance of any unlawful purpose; (d) use IREx to disseminate, store or transmit any files, graphics, software or other material that may be defamatory, libelous, obscene, unlawfully threatening or harassing, or that infringes another’s intellectual property rights or other rights; (e) transmit any virus, software program, segment of code or other programming design, instruction, or routine that permits unauthorized access to IREx or related data, or that is intended to damage, interfere with, intercept, or expropriate IREx or related data; or (f) distribute through IREx any software, code or other items designed to interfere with or compromise the privacy, security or use of Our assets or assets of any other person or entity. You shall not remove, obscure or alter any disclaimers, or notices, including without limitation, copyright notice, trademark or other proprietary rights notices displayed or contained within IREx.

Data.

Data Generally. You acknowledge that IREx contains study documents, such as template and approved consent and authorization forms, study protocols, recruitment material, and other documents (“IRB Data”) and/or data supplied by third parties (“Third Party Data”). Under no circumstances will We be responsible or liable for the accuracy, availability or completeness of any IRB Data or Third Party Data. You are solely responsible for the accuracy, availability and completeness of any data or information submitted to IREx by You or on Your behalf (“Your Data”). You hereby authorize Us to use and reproduce Your Data for purposes of operating IREx and otherwise contemplated by these Terms (which includes, among other things, making the data available to other Participating Sites), and for back-up, restoration, reconfiguration, and all other maintenance purposes. We reserve the right to remove portions of the IRB Data, Third Party Data or Your Data from IREx at any time in our sole discretion.

Compliance. You must comply with all applicable laws and regulations in connection with your use of IREx. HIPAA requirements related to the protection of Protected Health Information under the Health Insurance Portability and Accountability Act (“HIPAA“) do not apply to IREx. Except for user information necessary to use IREx, You may not upload into IREx any data or information that identifies, or permits the identification of, any individual, including, but not limited to, any Protected Health Information as that term is defined in HIPAA and its implementing regulations (“Personal Information“). In the event that any Personal Information is nevertheless uploaded to, or otherwise available through, IREx, You may not download, copy, or disclose (or permit any person to download, copy or disclose) the Personal Information under any circumstances. Likewise, You may not use IREx to comply with any Food and Drug Administration (“FDA“) records requirements; You are solely responsible for maintaining Your own FDA compliant records systems.

Confidentiality.

Definition. “Confidential Information” means any information, documentation, data, system, or process disclosed by a party, a Participating Site or any of their affiliates that is (i) designated as confidential (or a similar designation) at the time of disclosure, (ii) disclosed in circumstances of confidence, including, without limitation, disclosed through IREx, or (iii) understood by the parties, exercising reasonable business judgment, to be confidential. Confidential Information does not include information that (a) was lawfully known or received by the receiving party without obligation of confidentiality prior to disclosure, (b) is or becomes part of the public domain other than as a result of a breach of these Terms, (c) was disclosed to the receiving party without obligation of confidentiality by a third party, provided such third party, or any other party from whom such third party receives such information, is not in breach of any confidentiality obligation in respect to such information, or (d) is independently developed by the receiving party as evidenced by independent written materials.

Obligations. Each party will keep confidential all Confidential Information it receives from the other party or its affiliates or through use of IREx. Each party will use disclosed Confidential Information only for the purpose of these Terms and an applicable Reliance Agreement, and will protect all Confidential Information against disclosure using a reasonable degree of care. Each party may disclose Confidential Information to its contractors if the contractor is contractually obligated to confidentially provisions that are at least as protective as those contained herein. If a receiving party is compelled by law to disclose Confidential Information of the disclosing party, the receiving party will use reasonable efforts to (i) seek confidential treatment for the Confidential Information, and (ii) if permissible, send sufficient prior notice to the other party to allow the other party to seek protective or other court orders.The confidentiality obligations in these Terms are in addition to, and not in lieu of, any other obligations, including, without limitation, any obligations pursuant to an applicable Reliance Agreement.

Ownership. As between You and Us, You maintain ownership of Your Data, and ownership of Third Party Data is retained by the applicable third party. If We receive a legal request or demand for Your Data, such as pursuant to a subpoena or from a regulatory or oversight agency, if permitted, We will attempt to notify You prior to disclosing Your Data and cooperate with You in responding. However, We may, after a reasonable period of cooperation, comply with Our legal obligations (for example, if no protective order is issued that would negate the legal request or demand). You acknowledge that We own all right, title and interest in IREx (but not Your Data or Third Party Data), including all related intellectual property rights. Except for the authorizations expressly granted in these Terms, nothing in these Terms confers in You any rights of ownership or use of IREx or the Third Party Data. You may not use Our name, logo, symbol, trademark, or other image or mark without Our prior written consent. We may list Your name (only) in a listing of all users of IREx, for the purpose of providing information regarding IREx to other users and potential users.

Limited Warranties/Disclaimer. WE MAKE NO WARRANTIES IN RESPECT OF ANY MATTER, INCLUDING WITHOUT LIMITATION IREX OR ANY DATA THEREIN, AND EXPLICITLY DISCLAIM ALL OTHER WARRANTIES, EXPRESS OR IMPLIED, INCLUDING THE IMPLIED WARRANTIES OR CONDITION OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, NON-INFRINGEMENT, OR QUIET ENJOYMENT. WE ARE NOT RESPONSIBLE FOR ANY THIRD PARTY SOFTWARE, SERVICE, DATA OR HARDWARE USED IN CONNECTION WITH IREX. IREX AND ALL IRB DATA AND THIRD PARTY DATA IS PROVIDED “AS IS,” WITH ALL FAULTS, AND THE ENTIRE RISK AS TO SATISFACTORY QUALITY, PERFORMANCE, ACCURACY AND EFFORT IS WITH YOU. WE DO NOT WARRANT THAT (A) THE OPERATION OF IREX WILL BE UNINTERRUPTED OR ERROR FREE; OR (B) ANY DEFECT OR MALFUNCTION IN IREX IS CORRECTABLE OR WILL BE CORRECTED.

Limitation of Liability. We shall have no liability or obligation for any claims, losses or damages arising out of or relating to IREx or these Terms (whether in contract, equity, negligence, tort or otherwise), and We are not responsible for any damages or losses arising from Third Party Data. Under no circumstances will We be liable for direct or indirect, special, incidental or consequential damages, including, without limitation, lost profit or loss resulting from business interruption, even if advised of the possibility or likelihood of such damages.

Insurance. You and we shall maintain insurance coverage of sufficient type(s) and in reasonable amount(s) to cover our respective activities in IREx. If a Participating Site is a state agency or an instrumentality of a state or federal government, self-funded liability coverage or relying on the applicable law of its state or federal jurisdiction to protect and limit its liability as an instrumentality of such state or federal government is allowable

Revision of Terms. These Terms constitute the entire agreement between You and Us with respect to IREx, superseding all other prior agreements that might exist. We may revise the Terms at any time by posting the revised Terms on IREx. All revised Terms are automatically effective as soon as they are posted. Your continued use of IREx constitutes your agreement to be bound by the revised Terms. The revision date of these Terms is stated at the bottom of this document.

Miscellaneous. Neither You nor We will be liable for any failure or delay in performing obligations under these Terms to the extent caused by circumstances that are beyond a party’s reasonable control. There are no third-party-beneficiaries of these Terms. A failure to enforce or delay in enforcing a provision of these Terms does not waive any right to enforce such provision or right or any other provision or right. You may not assign these Terms without Our written consent. You and We are each independent contractors and not an agent of the other. Neither party has the power to bind the other. Each party is responsible for its own expenses and employees. We may provide notices via posting through IREx. The invalidity or unenforceability of any provision of these Terms will not affect the validity or enforceability of the remainder, and the provision affected will be construed so as to be enforceable to the maximum extent permissible by law.

ACCEPTANCE

BY CHECKING “I AGREE,” YOU ACKNOWLEDGE THAT YOU HAVE READ AND UNDERSTAND THESE TERMS AND THAT YOU AGREE TO COMPLY WITH ITS TERMS. DO NOT CHECK “I AGREE” OR ACCESS IREX IF YOU DO NOT ACCEPT THESE TERMS.